BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATELLA IMPLANT

    MDR report key: 12467013 · Received September 13, 2021

    Report

    Report Number
    MW5103885
    Event Type
    Malfunction
    Date Received
    September 13, 2021
    Date of Event
    August 18, 2021
    Report Date
    September 9, 2021
    Manufacturer
    UNITED ORTHOPEDIC CORP.
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD PATELLA IMPLANT FAILURE AFTER ONLY ONE YEAR OF USE. PATIENT REQUIRED REPEAT SURGERY. PATIENT ALSO HAD 11MM SIZE 6 INSERT 2303-3662, LOT# 17G134BX. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1360785 PATELLA IMPLANT PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH UNITED ORTHOPEDIC CORP. 32MM 2403-3240 19F433F

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other